On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

On June 24, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA (loncastuximab tesirine-lpyl) franchise.

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As part of the reorganization, ADC Therapeutics plans to reduce its workforce globally by approximately 17 percent. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint to support ZYNLONTA.

"As we further assess the Phase 3 LOTIS-5 trial outcomes, including feedback from key medical experts, we continue to believe in the favorable overall benefit-risk profile and look forward to our pre-sBLA meeting with the U.S. Food and Drug Administration in August," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This strategic reorganization will enable us to increase our financial flexibility as we prepare for upcoming LOTIS-5 regulatory milestones and continue building on the broader opportunity for ZYNLONTA through LOTIS-7 and support for the indolent lymphoma investigator-Initiated trials. We are grateful to all of our employees for their efforts to help make a meaningful impact for patients and thank them for their important contributions to our company."

The Company is preparing for a scheduled pre-sBLA meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) following the recent topline data results from the Phase 3 LOTIS-5 trial. ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026.

In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL, with data anticipated by the end of 2026, as well as through support for Phase 2 IITs exploring ZYNLONTA across indolent lymphomas.

ADC Therapeutics expects the reorganization to generate annualized estimated cost savings of approximately $10 million. ADC Therapeutics estimates that it will incur one-time pre-tax charges of approximately $3 million for employee severance, benefits and related termination costs, the majority of which will be recognized in the 2nd quarter of 2026. The Company has an expected cash runway at least into 2028.

About ZYNLONTA

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

(Press release, ADC Therapeutics, JUN 24, 2026, View Source [SID1234668931])

On June 24, 2026 Passage Bio, Inc. (Nasdaq: PASG) ("Passage Bio") and Remix Therapeutics, Inc. ("Remix"), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported that they have entered into a definitive merger agreement to combine in an all-stock transaction. Upon completion of the transaction, the combined company plans to operate under the name Remix Therapeutics, Inc. and expects to trade on Nasdaq under the ticker symbol "RMTX."

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In connection with the proposed merger, Remix has secured commitments for a concurrent oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100 million from a syndicate of new investors led by Decheng Capital, with participation from Lynx1 Capital Management, Forge Life Science Partners, existing investors and other leading investment management firms.

The private placement financing is expected to close immediately prior to completion of the proposed merger. The combined company’s cash and cash equivalents balance at closing, including the proceeds from the private placement, is anticipated to fund the combined company’s operations into 2028 and provide runway through key clinical milestones, including data from the registrational Phase 2 trial of REM-422 in Adenoid Cystic Carcinoma (ACC); data from the Phase 1 trial in Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) and progression of Remix’s discovery pipeline.

"This transaction marks a transformative step for Remix as we advance our mission to reprogram RNA processing and unlock a new class of medicines with the strength of our seasoned team and support from leading biotechnology investors," said Peter Smith, Ph.D., Co-Founder and CEO of Remix. "We are exceptionally well-positioned to accelerate a pipeline of RNA-targeted small-molecule therapies led by REM-422, an orally available mRNA degrader targeting MYB, a historically undruggable transcription factor implicated across multiple cancers. With this strengthened foundation and compelling REM-422 data in hand, we are focused on rapidly translating our breakthrough science into differentiated therapies for patients who urgently need better options."

"Following a thorough evaluation of strategic alternatives, we are thrilled to have identified Remix as the ideal partner for this transaction. Remix has built a truly differentiated platform in RNA processing modulation, and REM-422’s impactful Phase 1 data in ACC and strong execution of their ongoing registrational study in this underserved disease reflect the quality of their science and team. We believe this combination delivers compelling value for Passage Bio stockholders, providing meaningful participation in a clinical-stage company with a well-defined path to pivotal data. We look forward to supporting the combined company as it advances these important medicines for patients," said Will Chou, M.D., President and CEO of Passage Bio.

About the Proposed Transaction
Under the terms of the merger agreement, as of the closing of the proposed merger, the pre-merger Passage Bio shareholders are expected to own approximately 7% of the combined company and the pre-merger Remix stockholders (inclusive of those investors participating in the financing) are expected to own approximately 93% of the combined company. The percentage of the combined company that Passage Bio shareholders will own as of the closing of the proposed merger is subject to adjustment based on the estimated amount of Passage Bio’s net cash immediately prior to the closing date. In connection with the proposed merger, a contingent value right ("CVR") will be distributed to Passage shareholders of record at the closing date. Each CVR will entitle its holder to receive a pro rata portion of certain net proceeds actually received by the combined company from milestones associated with Passage Bio’s out-licensed pediatric gene therapy pipeline assets, subject to the terms and conditions of a CVR agreement to be entered into at closing. The CVRs will not be transferable (except in limited circumstances), will not be listed on any securities exchange, and will not bear interest. There can be no assurance that any proceeds will be realized or that CVR holders will receive any payment.

The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the fourth quarter of 2026, subject to the satisfaction of customary closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (the "SEC") to register the securities to be issued in connection with the proposed merger and the satisfaction of other customary closing conditions.

The combined company plans to operate under the name Remix Therapeutics, Inc. and will be led by Dr. Smith. Remix’s Board of Directors will become directors of the combined company, chaired by Matthew Patterson. In conjunction with the transaction, Peter Colabuono of Decheng Capital will join the Board of Directors.

Latham & Watkins LLP is serving as legal counsel to Remix. Goldman Sachs & Co. LLC, Jefferies and Evercore ISI are acting as the placement agents in connection with the concurrent private placement financing. RBC Capital Markets and Canaccord Genuity are acting as Capital Markets Advisors. Cooley LLP is serving as legal counsel to the placement agents. Fenwick & West LLP is serving as legal counsel to Passage Bio. Wedbush Securities Inc. is serving as exclusive financial advisor for the transaction.

Conference Call and Webcast Information
The companies will host a conference call and webcast on June 24, 2026 at 4:30 P.M. ET. Participants are invited to listen here or by visiting the Investors & Media section of Passage Bio’s website at investors.passagebio.com.

About REM-422
REM-422 is a potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

(Press release, Remix Therapeutics, JUN 24, 2026, View Source [SID1234668946])

On June 24, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones that position the Company for what management believes could be a pivotal period in its evolution as a clinical-stage oncology company.

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At the center of AIM’s strategy is Ampligen (rintatolimod), the Company’s proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.

Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. AIM believes Ampligen’s unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease.

Execution Continues to Drive Momentum

Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development:

Completed Phase 2 DURIPANC enrollment ahead of schedule
Achieved the important clinical milestone of dosing the final patient in the study
Reported positive interim clinical updates from the ongoing trial
Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates
Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center
Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations
Maintained orphan drug designation for pancreatic cancer in major markets
Regained compliance with NYSE American continued listing standards
Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities
These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway.

Growing Clinical Foundation Supports Advancement

Ampligen’s pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations.

Recent interim updates from DURIPANC have continued to support management’s confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition.

Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment.

Multiple Near-Term Catalysts Ahead

With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company’s recent history.

Key anticipated milestones include:

Additional clinical updates from the ongoing DURIPANC study
Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027
Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027
Continued immune monitoring and biomarker analyses
Regulatory interactions supporting future development planning
Further expansion of the Company’s global intellectual property portfolio
Advancement of Phase 3 planning activities
Potential design and initiation activities associated with a registration-focused pivotal study
Management believes each of these milestones has the potential to further validate Ampligen’s clinical profile and strengthen the Company’s strategic position.

A Clear Focus on Shareholder Value Creation

AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value.

The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority.

As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise.

With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period.

"We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders."

As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment today.

(Press release, AIM ImmunoTech, JUN 24, 2026, View Source [SID1234668932])